Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.

A population-based observational study of diabetes during pregnancy in Victoria, Australia, 1999-2008

Objectives: This paper reports secular trends in diabetes in pregnancy in Victoria, Australia and examines the effect of including or excluding women with pre-existing diabetes on gestational diabetes (GDM) prevalence estimates.

Mothers after gestational diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.

Methods/Design:
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.

Discussion:
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial

Background
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes.

Methods/Design
The original protocol was published in Trial s (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion “surgical or medical intervention to treat obesity” has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy.

Prevention of type 2 diabetes in a primary health care setting interim results from the Greater Green Triangle (GGT) Diabetes Prevention Project

Although clinical trials have shown that lifestyle modifications reduce the risk of type 2 diabetes, translating lessons from trials to primary care remains a challenge. The aim of the study was to evaluate efficacy and feasibility of primary care-based diabetes prevention model with modest resource requirements in rural Australia. Three hundred and eleven subjects with at least a moderate risk of type 2 diabetes participated in a combined dietary and physical activity intervention. Clinical measurements and fasting blood samples were taken at the baseline and after intervention. After 3 months intervention, total (change &minus;3.5%, p < 0.001) and LDL cholesterol (&minus;4.8%, p < 0.001) plasma levels as well as body mass index (&minus;2.5%, p < 0.001), weight (&minus;2.5%, p < 0.001), and waist (&minus;1.6%, p < 0.001) and hip (&minus;2.7%, p < 0.001) circumferences reduced significantly. A borderline reduction was found in triglyceride levels (&minus;4.8%, p = 0.058) while no changes were observed in HDL cholesterol (+0.6%, p = 0.525), glucose (+0.06%, p = 0.386), or systolic (&minus;0.98%, p = 0.095) or diastolic (&minus;1.06%, p = 0.134) blood pressure levels. In conclusion, a lifestyle intervention improved health outcomes – especially obesity and blood lipids – in a population at high risk of developing type 2 diabetes. Our results suggest that the present model is effective and feasible to carry out in primary care settings.

Family average income and diagnosed Type 2 diabetes in urban and rural residents in regional mainland China.

Aims: To explore the relationship between family average income (FAI; an index of socio-economic status) and Type 2 diabetes in a region of mainland China. Methods: Population-based cross-sectional study, conducted between October 2000 and March 2001 in administrative villages (n = 45) randomly selected from three urban districts and two rural counties of NanJing municipality, mainland China, with a regional population of 5.6 million. Participants were all local residents aged ≥ 35 years old (n = 29 340); 67.7% from urban areas, 32.3% from rural areas, 49.8% male and 50.2% female. Results: The response rate of eligible participants was 90.1%. The overall prevalence of self-reported Type 2 diabetes was 1.9%. After adjustment for possible confounding variables (age, gender, area of residence, body mass index, educational level, smoking status, occupational and leisure-time physical activity), participants in the higher and middle FAI categories were more than twice as likely to have Type 2 diabetes as those in the lower FAI category. Conclusions: The prevalence of Type 2 diabetes is positively related to socio-economic status (indexed by FAI) in Chinese at the population level. After controlling for potential confounding factors, people in higher socio-economic status groups are more likely to have Type 2 diabetes. These associations are consistent with other effects of epidemiological transition and identify a need for preventive initiatives.

Smoking cessation programs in pregnancy: systematically addressing development, implementation, women's concerns and effectiveness

Objectives:  To increase a review's relevance to practitioners and service users and identify the implications for systematic review methodology. Methods:  A systematic review of the effects of smoking cessation programmes implemented during pregnancy integrated process indicators and the views of maternity service users and health promotion specialists. Additional qualitative data were extracted systematically from included randomised control trials (RCTs) to determine whether the design of interventions and conclusions arising from their evaluation related to the views of service users. On completing the review we reflected on the types of observational and qualitative research it drew on, where this research was incorporated into the review, and its added value. Results:   Incorporating process indicators into the review revealed: 1) problems with implementation and transplantation of some interventions and 2) studies with more stringent quality criteria and process evaluations demonstrated greater impact (weighted mean difference in smoking). Pregnant smokers were rarely involved in the design or evaluation of the interventions. Prior observational and qualitative studies and small scale consultations influenced the criteria by which the effectiveness of the interventions were judged, and revealed to what extent these criteria are adopted in practice.
Conclusions:   Systematically abstracting data about the development and delivery of interventions revealed gaps that might be filled by the active involvement of service users.

Checks and cheques : implementing a population health and recall system to improve coverage of patients with diabetes in a rural general practice

Identification of all diabetic patients in the population is essential if diabetic care is to be effective in achieving the targets of the St Vincent Declaration.¹ The challenge therefore is to establish population based monitoring and control systems by means of state of the art technology in order to achieve quality assurance in the provision of care for patients with diabetes. ^2,3 Disease management receives extensive international support as the most appropriate approach to organising and delivering healthcare for chronic conditions like diabetes.⁴ This approach is achieved through a combination of guidelines for practice, patient education, consultations and follow up using a planned team approach and a strong focus on continuous quality improvement using information technology. ^5,6 The current software (Medical Director) could not easily meet these requirements which led us to adopt a trial of Ferret. In designing this project we used change management⁷ and the plan, do, study, act cycle⁸ illustrated in Diagram 1.